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FDA Approves Biotechnology Drug To Treat Skin Condition Psoriasis

The FDA has approved Biogen's Amevive, the first-ever drug developed by a biotechnology company to treat psoriasis, the New York Times reports. The drug could help reduce the effects of psoriasis without causing the side effects associated with current treatments, including liver and kidney damage. Psoriasis, an autoimmune disorder that about 1.5 million adults in America experience on a moderate to severe scale, causes reddened skin covered by a "silvery scale." Amevive, a genetically engineered protein, works by blocking T cells that have mistakenly "attack[ed]" a patient's skin. Because T cells also protect patients from infection, people receiving Amevive will need to have their T cells checked weekly and must wait at least 12 weeks after receiving one course of treatment before receiving another. In clinical trials, Amevive produced a 75% improvement in psoriasis for between 15% and 40% of patients, depending on the method of administration and the length of treatment. Amevive will be administered as an injection in a doctor's office once a week for 12 weeks. Biogen is expected to sell the treatment for between $7,000 and $10,000 for the 12-week course, and patients and insurers will likely pay between $8,400 and $11,900 for the entire course, according to Ronald Renaud, an analyst for Bear, Stearns. Biogen officials said they expect Amevive will bring in $85 million this year and $500 million in 2005. However, some analysts predict Biogen will not earn that much on Amevive because other psoriasis drugs are expected to come to market soon. Amgen's Enbrel, a treatment already proven safe to treat rheumatoid arthritis and psoriatic arthritis, is now in late-stage trials to treat psoriasis, and Genentech, Xoma and Johnson & Johnson are also developing psoriasis treatments (Pollack, New York Times, 2/1).

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